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Hindawi Publishing Corporation

Evidence-Based Complementary and Alternative Medicine


Volume 2013, Article ID 204259, 12 pages
http://dx.doi.org/10.1155/2013/204259

Research Article
A Longitudinal Study of the Reliability of Acupuncture Deqi
Sensations in Knee Osteoarthritis

Rosa B. Spaeth,1 Stephanie Camhi,2 Javeria A. Hashmi,1 Mark Vangel,3,4 Ajay D. Wasan,5
Robert R. Edwards,5 Randy L. Gollub,1,3 and Jian Kong1,3
1
Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA 02129, USA
2
Department of Psychology, Endicott College, Beverly, MA 01915, USA
3
MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA 02129, USA
4
Department of Radiology, Massachusetts General Hospital, Charlestown, MA 02129, USA
5
Departments of Anesthesiology, Perioperative and Pain Medicine and Psychiatry,
Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA

Correspondence should be addressed to Jian Kong; kongj@nmr.mgh.harvard.edu

Received 26 April 2013; Revised 6 June 2013; Accepted 7 June 2013

Academic Editor: Gerhard Litscher

Copyright © 2013 Rosa B. Spaeth et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Deqi is one of the core concepts in acupuncture theory and encompasses a range of sensations. In this study, we used the
MGH Acupuncture Sensation Scale (MASS) to measure and assess the reliability of the sensations evoked by acupuncture needle
stimulation in a longitudinal clinical trial on knee osteoarthritis (OA) patients. The Knee injury and Osteoarthritis Outcome Score
(KOOS) was used as the clinical outcome. Thirty OA patients were randomized into one of three groups (high dose, low dose,
and sham acupuncture) for 4 weeks. We found that, compared with sham acupuncture, real acupuncture (combining high and
low doses) produced significant improvement in knee pain (𝑃 = .025) and function in sport (𝑃 = .049). Intraclass correlation
analysis showed that patients reliably rated 11 of the 12 acupuncture sensations listed on the MASS and that heaviness was rated
most consistently. Overall perceived sensation (MASS Index) (𝑃 = .014), ratings of soreness (𝑃 = .002), and aching (𝑃 = .002)
differed significantly across acupuncture groups. Compared to sham acupuncture, real acupuncture reliably evoked stronger deqi
sensations and led to better clinical outcomes when measured in a chronic pain population. Our findings highlight the MASS as a
useful tool for measuring deqi in acupuncture research.

1. Introduction acupuncture sensations is that perception of deqi is subjective


and the specific sensations associated with deqi may vary
Deqi (obtaining qi) is a core concept in traditional Chinese significantly both between and within individuals, which
acupuncture theory [1, 2] that describes the physiological calls for the development of a systematic measurement of
link between the stimulation of acupuncture needles and deqi sensation. To overcome this barrier, in recent years,
the energy meridians running through the body [2–5]. The investigators have started to use different scales to measure
term deqi encompasses numerous sensations (e.g., soreness, deqi sensation [2, 10–16] and have investigated the association
heaviness), the complete range of which is debated [6–8]. between deqi sensation and therapeutic effects [13, 17, 18].
Traditional ancient acupuncturists believed that deqi It is generally believed that deqi sensation is crucial for
was comprised of sensations and/or experiences of both effective acupuncture treatment, a belief rooted in traditional
the patient receiving the treatment and the acupuncturist Chinese acupunture theory [2]; however, the link between
administering the treatment [7–9]. Modern acupuncturists these sensations and improvements in clinical outcomes
and researchers, however, have emphasized the patient’s remains unclear [19, 20]. Previous studies investigating the
sensations rather than the acupuncturist’s experience dur- relationship between deqi sensations and clinical outcomes
ing needling [10–13]. One challenge in investigating these are contradictory [21–24]. It is important to note that most
2 Evidence-Based Complementary and Alternative Medicine

studies use deqi as a general construct [25] and that none Subjects were included if they met the Kellgren-Lawrence
of these studies explored the association between clinical scale for radiographically grading knee OA [27–29] as grade 2
outcomes and specific, quantified sensations [21–24]; rather, or 3. Those with severe knee OA were excluded. Other specific
these studies investigated the difference between traditional inclusion and exclusion criteria were designed to allow for
Chinese acupuncture (with deqi) and sham acupuncture the retention of a relatively homogenous clinical population;
(with no or minimal deqi sensation). In a previous study subjects were excluded for any interventional procedure for
in healthy subjects, we developed an acupuncture sensa- knee pain within 6 months prior to enrolling in the study,
tion scale [13] to measure the sensations evoked by elec- intent to undergo surgery during the time of involvement in
troacupuncture, manual acupuncture, and sham acupunc- the study, knee pain due to other causes such as inflammation
ture. This scale has subsequently been revised, renamed, or malignancy, diagnosis of rheumatoid arthritis or other
and used in other acupuncture research studies including pain disorders that may refer pain to the leg, medications
the present study [2, 26]. In our previous study, we found or disorders that would put patients at heightened potential
that numbness and soreness were significantly associated for adverse outcome, and presence of MRI contraindications
with analgesia to experimental heat pain [13]. Nevertheless, (e.g., cardiac pacemaker, metal implants, claustrophobia, and
few studies have systematically measured and characterized pregnancy). All OA patients had an endogenous knee pain
deqi sensations in a patient population longitudinally and intensity rating (average in the last week) of >2 on a 0 to 10
explored the association between quantified deqi sensations scale at the first visit.
and clinical outcomes.
In the present study, we longitudinally investigated 2.3. Experimental Design. To maintain consistency within
acupuncture treatment-evoked deqi sensations in a chronic our sample of patients who had both unilateral and bilateral
pain population using the Massachusetts General Hospital knee pains, we only treated one knee for each subject. For
(MGH) Acupuncture Sensation Scale (MASS) and explored those subjects with bilateral knee pain, the knee with the
the association between deqi sensations and changes in highest pain ratings was treated. Subjects were stratified by
clinical outcomes related to knee pain. More specifically, knee knee and randomized into one of the three groups: high-dose
osteoarthritis (OA) patients were randomized into one of real acupuncture (6 acupoints), low dose real acupuncture
three treatment groups: high-dose acupuncture treatment (2 acupoints), and high-dose sham acupuncture (6 nonacu-
(application of six acupuncture points), low-dose acupunc- points with Streitberger placebo needles) (see Figure 1).
ture treatment (application of 2 acupuncture points), and
sham acupuncture (Streitberger placebo acupuncture needles
on 6 nonacupoints). We employed a tapered longitudinal 2.4. Blinding. At the time of consent, all patients were
treatment design [21], such that each patient received 6 informed that they would receive one of three modes of
acupuncture treatments over the course of 4 weeks (2 treat- acupuncture treatment and that there was an equal chance of
ments per week for the first 2 weeks and one treatment per receiving each mode of treatment. Using specially designed
week for the last 2 weeks). Deqi sensations were measured placebo needles (described below) and acupuncture-naı̈ve
using the MASS twice during each treatment. And after subjects, we were able to keep all subjects blinded to acupunc-
the six-session acupuncture treatment period, the Knee ture mode (real versus sham acupuncture). Subjects were
injury and Osteoarthritis Outcome Score (KOOS) was also not told how many needles would be used in the high-
administered to investigate changes in knee pain and function versus low-dose acupuncture groups. All clinical outcomes
following treatment with either real or sham acupuncture. detailed below were measured by research staff, also blinded
to treatment condition; thus, the study was single blinded
(patients and research staff were blinded; acupuncturist was
2. Materials and Methods not blinded).
2.1. Subjects. The Institutional Review Board at the Mas- After an initial screening session, each subject engaged in
sachusetts General Hospital approved all study procedures. a total of 6 acupuncture-treatment sessions, completing the
All subjects provided written informed consent at the begin- MASS form twice within each session. Treatments 1, 3, and
ning of the study and were debriefed at the end of the study. 6 occurred approximately 15 minutes into a scan session in
which the patient was lying in a 3 Tesla Tim Trio magnetic
2.2. Patient Recruitment and Inclusion Criteria. Acupunc- resonance imaging scanner (Siemens, Erlangen, Germany)
ture naı̈ve patients aged 40–70 with a diagnosis of chronic while functional imaging data was acquired. The remaining
painful osteoarthritis (OA) in the right and/or left knee treatments were administered in a behavioral testing room
were recruited for this study, as previous studies have indi- with patients reclined in a chair. All acupuncture treatments
cated that acupuncture is an effective treatment for patients were completed within four weeks.
with chronic knee pain [21–23]. Investigators excluded
acupuncture-experienced subjects to minimize the possi- 2.5. Acupuncture Administration. High- and low-dose
bility of subjects distinguishing sham from real acupunc- acupuncture groups differed only in the number of acupoints
ture, serving to assist in blinding the subjects to their stimulated. In the high-dose group, 6 needles were inserted at
assigned treatment group. Patients were recruited from the 6 acupoints (see Figure 2(a)), and each point was stimulated
Massachusetts General Hospital (MGH) and Brigham and 4 times. In the low-dose group, 2 needles were inserted, and
Women’s Hospital (BWH). each point was stimulated a total of 12 times. The total length
Evidence-Based Complementary and Alternative Medicine 3

Assessed for
eligibility
(N = 44) Excluded (N = 10)
∙ Scheduling (N = 4)
∙ Ineligibility at screening (N = 3) Xiyan SP 9
∙ Disinterest (N = 2) GB 34
∙ Claustrophobia (N = 1) ST35
Stratified by knee and Sham 1
randomized (N = 34) Sham 1
Sham 2
Sham 2
Sham 3
Sham 3

Allocated to Allocated to Allocated to


low-dose high-dose sham
acupuncture acupuncture acupuncture
(N = 12) (N = 12) (N = 10)
∙ Received ∙ Received ∙ Received
complete complete complete SP 6
intervention GB 39
intervention intervention
(N = 10) (N = 10) (N = 10)
∙ Did not ∙ Did not
receive receive
complete complete
intervention intervention
(N = 2) (N = 2) (a)
10 30 10 30 10 30 10 30 10 30 10 (sec)
Discontinued Discontinued Discontinued Ml M2 M3 M4 M5 M6
intervention intervention intervention Needles in Needles out
∙ Scheduling ∙ Noncompliance
(N = 0)
(N = 2) in scanner
(N = 2) 0 30 s 4 6 9.5 10 15 15.5 19 21 24.5 25(min)
Real/sham acupuncture Real/sham acupuncture
MASS1 MASS2
Analyzed Analyzed Analyzed
(b)
(N = 10) (N = 10) (N = 10)
Figure 2: Standardized acupuncture protocol. (a) Real and sham
Figure 1: Consort diagram indicating the number of patients
acupuncture points. Low-dose real acupuncture was applied on
enrolled, dropped, and completed, by group.
ST35 and Xiyan (extra point). High-dose acupuncture group was
applied to four additional points: GB34, SP9, GB39, and SP6. Six
sham acupuncture points were used for the sham acupuncture
group. (b) Acupuncture stimulation paradigm for both real and
placebo acupunctures, indicating the timeline of intermittent needle
of the treatment remained constant across all treatment stimulation during each acupuncture treatment. Six 10-second
groups. All other treatment parameters, as described below, periods of manual needle rotation (M) were separated by 30 seconds
of rest. The manual stimulation series (M1–6) was repeated a total
were held constant (Figure 2(b)).
of 4 times, twice prior to administering the first MASS, and an
Each acupuncture treatment session for subjects in both additional 2 times prior to the second MASS.
the real and the sham acupuncture groups was about 25
minutes in duration and was carried out by the same licensed
acupuncturist. For all treatments, the acupuncturist located
the acupoints on the leg, disinfected each point with isopropyl
alcohol, and then placed a small plastic ring over the point, The high-dose acupuncture group received treatment at
securing the ring with a thin strip of sterile plastic tape. This four additional points including GB34, SP9, GB39, and SP6
ensured patient blindness to the actual site of needle insertion (see Figure 2(a)).
and thus blindness to whether the treatment was real or sham. For consistency, leg position, acupoint location, and
For all patients, a predetermined number of acupoints (either needling parameters (1-2 cm depth, approximately 120 rota-
2 or 6) were stimulated in a predetermined order for a total tions per minute, 90∘ insertion angle, and moderate deqi
of 24 stimulations (Figure 2(b)). sensations on a 0–10 scale) were kept constant across groups.
Needles were rotated at each point for 10 seconds with
30-second breaks between each point (see Figure 2(b)). All
2.5.1. Real Acupuncture Treatments. For the low-dose points (either 2 or 6 acupoints) were stimulated one point at
acupuncture group, real acupuncture was applied to ST35 a time and were stimulated in a predetermined order. In the
and Xiyan (extra point) (see Figure 2(a)). These two high-dose group, needles were manipulated in the order of
acupuncture points are well documented for treating knee GB34, SP9, ST35, Xiyan (extra point), GB39, and SP6. The
pain according to traditional Chinese acupuncture [9, 30]. specific starting acupoint was randomized across patients,
Both points, located near the knee, have been used in but within patients, the starting point was held constant
previous clinical trials of OA patients [21–23]. across sessions.
4 Evidence-Based Complementary and Alternative Medicine

2.5.2. Placebo Acupuncture Procedures. Placebo acupuncture All subjects were asked to rate their acupuncture sensa-
was applied at six nonacupoints using Streitberger placebo tions using the MASS twice during each treatment. Subjects
needles specially designed for subject blinding [13, 31–35] were asked to report the average sensation across all of the
using a paradigm identical to the real acupuncture treatment. needles used for their treatment (either 2 or 6, depending
These sham needles are visually indistinguishable but differ on the group). Prior to the first treatment, the acupuncturist
from regular needles by virtue of their blunt, retractable tip. gave all subjects a brief description of deqi, as subjects were
Instead of penetrating the skin, the point of the Streitberger acupuncture naı̈ve upon enrollment. Each subject was told
needle retracts up into the shaft when the acupuncturist the following: “The MGH Acupuncture Sensation Scale lists
presses it against the skin. This sham device has been 12 of the sensations commonly reported by people who
validated by studies showing that subjects cannot distinguish receive acupuncture. Different patients experience different
between real and sham needling [13, 31, 32]. sensations, and you might not experience all of the sensations.
Six sham points were used during placebo acupuncture: If you feel a sensation that is not listed here, you may write in
sham point 1 was located 1.5 cun posterior and inferior to the sensation you feel and indicate how intensely you felt that
GB34, sham points 2-3 were located 1.5 cun and 3 cun inferior sensation.” The MASS was used to measure average sensations
to sham point 1, sham point 4 was located 1 cun posterior during needle stimulation across each 10-minute treatment
to the midpoint of K9 and K10, and sham points 5-6 were period. After the first block of intermittent acupuncture
located 1.5 cun inferior and superior to the sham point 4 stimulation (see Figure 2(b)), subjects were asked to indicate
separately (see Figure 2(a)). All sham points were located on the extent to which each of the 12 descriptors described their
the lower leg where no meridians pass through. Placebo treat- subjective acupuncture experiences. Subjects were asked to
ment administration was similar to high-dose acupuncture repeat this assessment again after the second 10-minute block
administration with regard to the number of acupoints. of intermittent stimulation.
The MASS index is a measure that describes the overall
2.6. Clinical Outcomes magnitude of deqi sensation experienced during treatment.
Using previously described methods [2], the index was
2.6.1. Knee Injury and Osteoarthritis Outcome Score (KOOS). calculated by ranking all of the sensations by self-reported
The Knee injury and Osteoarthritis Outcome Score (KOOS) intensity ratings (0–10) and then assigning a weight to each
[36] was used to measure clinical outcomes. The KOOS is sensation based on rank.
comprised of 5 subscales, each of which produces an outcome
score. These subscales include pain, other symptoms, func- 2.7. Data Analysis. Statistical analyses were performed using
tion in daily living (ADL), function in sport and recreation, SPSS 18.0 Software (SPSS Inc., Chicago, IL, USA). Variance in
and knee-related quality of life (QOL). Based on previous baseline characteristics, intensity ratings of each individual
studies, subscale scores of the KOOS related to pain, function sensation, the overall sum of all sensations, and the MASS
in daily living, and function in sport and recreation were index across treatment modalities were analyzed using a one-
selected as the primary outcome of the present study [21]. way ANOVA and post hoc t-tests (𝑃 < .05) and were
Other subscores were used for exploratory analyses. Trained corrected for multiple comparisons. All confidence intervals
research assistants, blinded to treatment mode, administered (CIs) are reported at the 95% confidence level.
the KOOS to all patients at baseline (within one week of The MASS index, a weighted average of the intensity of
the first treatment) and at the final (sixth) treatment. For sensations elicited, was calculated using previously published
each subscale, a normalized score was calculated, where 0 methods [2]. In brief, for each administration of the MASS (12
indicated the most extreme symptoms/pain and 100 indicated per subject), the deqi sensation descriptors (soreness, aching,
no symptoms/pain [36]. etc.) were ordered from the highest to the lowest subjective
intensity rating. As previously suggested, ratings of sharp
2.6.2. Massachusetts General Hospital Acupuncture Sensation pain were excluded from the MASS index calculation, as
Scale (MASS). The Massachusetts General Hospital (MGH) sharp pain is not always considered a deqi sensation. Using
Acupuncture Sensation Scale (MASS) [2] is the revised exponential smoothing, a weighted average (MASS index)
version of the Subjective Acupuncture Sensation Scale that was calculated.
has been used in previous studies in healthy subjects [13]. The internal consistency reliability of the MASS scale
This scale includes 12 descriptors (soreness, aching, deep was computed and results are presented as Cronbach’s alpha.
pressure, heaviness, fullness/distension, tingling, numbness, Measures of the test-retest reliability of each individual
sharp pain, dull pain, warmth, cold, and throbbing) that sensation, the overall sum of all sensations, and the MASS
are considered to be associated with acupuncture treatment index were computed using intraclass correlation coefficients.
and one supplementary field for subjects to describe the To compare how frequently each sensation was rated ≥1 on
acupuncture sensation in their own words [2]. Subjects were a scale from 0 to 10 across the 3 groups, a chi-square test
asked to rate the intensity of each sensation on a scale from for independence was conducted for each sensation. For
0 to 10, where 0 is none and 10 is unbearable. This scale was each chi-square test, we compared the number of people
created through a collaboration of acupuncture researchers at who reported that sensation at least once throughout the 6
the MGH Martinos Center and has been used by acupuncture treatments across the three groups.
researchers since 2007 [26, 37]. The MASS has subsequently Factor analysis was performed using the principal
been translated and validated in Chinese [38]. component extraction method to segment acupuncture
Evidence-Based Complementary and Alternative Medicine 5

Table 1: Baseline characteristics.


Mean ± SD All High dose Low dose Sham
N 30 10 10 10
Gender 13 Females 2 Females 7 Females 4 Females
Age 57.5 ± 8.3 60.1 ± 8.9 58.30 ± 8.6 54.1 ± 7.3
Duration (treated knee, years)∗ 10.5 ± 8.3 9.8 ± 7.4 5.7 ± 6.0 16.22 ± 8.3
KOOS pain 55.94 ± 14.10 58.61 ± 12.99 53.09 ± 9.39 56.11 ± 19.15
KOOS symptoms 52.98 ± 16.17 57.14 ± 19.12 48.21 ± 10.68 53.57 ± 17.82
KOOS ADL 63.58 ± 15.34 66.03 ± 11.83 61.18 ± 13.83 63.53 ± 20.34
KOOS sport† 29.48 ± 22.92 30.00 ± 18.11 31.16 ± 19.06 28.50 ± 30.92
KOOS QOL 38.75 ± 15.25 41.88 ± 16.94 38.13 ± 13.96 36.25 ± 15.81
Significant main effect of group (high versus low versus sham) indicated by ∗ ; † indicates 𝑁 = 29 due to one missing KOOS subscale score (low-dose group).

sensations (MASS) into meaningful clusters. Component (𝐹(2, 27) = 2.178, 𝑃 = .133) or function in sport (𝐹(2, 26) =
extraction was based on eigenvalues greater than 1.0 with 2.047, 𝑃 = .149) (see Figure 3(a)). Post hoc tests indicated no
no specifications for a fixed number of factors to extract. significant differences between the high- and low-dose real
A Varimax rotated solution with 25 maximum iterations acupuncture groups for pain (𝑃 = .612), function in daily life
for convergence was analyzed. Factors were loaded with a (𝑃 = 1.0), and function in sport (𝑃 = 1.0).
cut-off value of 0.4 (representing 16% variance). Pearson’s To increase power in our analysis, we combined the two
correlations were applied to examine the potential relation- real acupuncture groups (high and low dose) to compare
ship between osteoarthritis treatment outcomes (KOOS) and real acupuncture (𝑁 = 20) to sham acupuncture (𝑁 =
the perceived intensity of select sensations identified by the 10). The results indicated a significant interaction between
principal component analysis (PCA). acupuncture mode (real versus sham) and time (baseline
versus endpoint) on our primary outcomes: the KOOS
subscale scores for pain (𝐹(1, 28) = 5.596, 𝑃 = .025) and
3. Results function in sport (𝐹(1, 27) = 4.252, 𝑃 = .049). In addition,
Forty-four (19 females) acupuncture naı̈ve patients aged 43– we found that our secondary outcome (KOOS subscale score
70 with a diagnosis of chronic painful osteoarthritis in the for quality of life (QOL)) showed significant improvement in
right and/or left knee enrolled in the study. Of the 44 the real acupuncture group after treatment compared with
patients who enrolled, 30 (13 females) completed all study the sham group (𝐹(1, 28) = 4.682, 𝑃 = .039) (see Figure 3(b)).
procedures. Ten of the 14 patients who did not complete all
study procedures dropped out prior to the first treatment 3.2. Acupuncture Deqi Sensations. In this study, subjects
due to ineligibility at screening (3), scheduling conflicts (4), reported deqi sensations at 2 different time points in each
claustrophobia (1), and lack of interest (2); the remaining 4 treatment session: after the first 10-minute acupuncture
patients who underwent at least one acupuncture treatment stimulation period and again after the second 10-minute
session dropped out for the following reasons: scheduling acupuncture stimulation period (see Figure 2(b)). In total,
conflicts (2, low-dose group) and inability to adhere to study 30 subjects completed 6 treatment sessions, and all but one
requirements in scanner (2, high-dose group) (see Figure 1). subject completed the MASS twice per treatment. For one
subject, the second deqi assessment was missing from 3
treatment sessions. For the internal consistency reliability
3.1. Clinical Outcomes. Of the 30 patients who completed all
analysis of the MASS, only complete data sets were used. For
study procedures, 20 were treated on their right knee, and
all other analyses, the first and second administrations of the
10 were treated on their left knee. Baseline characteristics are
MASS in each treatment were averaged for each sensation.
detailed in Table 1. One subject in the low-dose acupuncture
group did not complete the KOOS subscale for function in
sport; thus, for all analyses including the KOOS function in 3.2.1. Internal Consistency Reliability of the MGH Acupuncture
sport variable only complete datasets (𝑁 = 29) were used. Sensation Scale (MASS). The Cronbach’s alpha reliability of
Repeated measurements analysis of pre- and post- the 12 items in the MASS was calculated for each admin-
treatment knee pain across three groups revealed a significant istration of the MASS (twice per treatment session) and
effect of time (baseline versus endpoint) on the KOOS ranged from 0.856 to 0.948 (see Table 2 for complete list of
subscales for pain (𝐹(1, 28) = 9.661, 𝑃 = .004, and 95% Cronbach’s alphas).
CI [2.75, 13.34]), function in daily living (ADL) (𝐹(1, 28) =
8.310, 𝑃 = .007, and 95% CI [2.61, 13.92]), and function 3.2.2. Test-Retest Reliability of Deqi Sensation across Different
in sport (𝐹(1, 28) = 6.145, 𝑃 = .0019, and 95% CI [2.04, Treatment Modes. Intraclass correlation analysis showed that
21.41]). A trend was observed for the interaction between patients rated soreness, aching, deep pressure, heaviness,
group and time on the KOOS pain subscale score (𝐹(2, 27) = fullness/distension, tingling, numbness, sharp pain, dull pain,
2.709, 𝑃 = .085) but not for either function in daily living warmth, and throbbing reliably across all 6 sessions (ICC
6 Evidence-Based Complementary and Alternative Medicine

Change in KOOS subscale scores Change in KOOS subscale scores


30

20
20
Mean change (post-pre)

Mean change (post-pre)


10 10

0 0

−10
−10

−20
Sham Real (low) Real (high) Sham Real
Acupuncture dose Acupuncture mode
Pain Sport Pain Sport
Symptoms QOL Symptoms QOL
Function Function
Error bars: +/−1 SE Error bars: +/−1 SE
(a) (b)

Figure 3: Changes in KOOS subscale scores from baseline to endpoint. Improvement in each of the 5 domains is indicated by a positive
value. (a) The interaction between group (high versus low versus sham) and time (baseline versus endpoint) showed a trend for the KOOS
pain subscale (𝐹(2, 27) = 2.709, 𝑃 = .085) but not for either function in daily living (𝐹(2, 27) = 2.178, 𝑃 = .133) or function in sport
(𝐹(2, 26) = 2.047, 𝑃 = .149). (b) The interaction between group (real versus sham) and time (baseline versus endpoint) was significant for
the KOOS subscale scores for pain (𝐹(1, 28) = 5.596, 𝑃 = .025), function in sport (𝐹(1, 27) = 4.252, 𝑃 = .049), and quality of life (QOL)
(𝐹(1, 28) = 4.682, 𝑃 = .039).

Table 2: Internal consistency of the 12-item MGH acupuncture cold sensation. Both the sum score and the MASS index
sensation scale (MASS). were highly reliable across all subjects and within each group
(see Table 3 for complete list of all intraclass correlation
Administration 1 Administration 2
coefficients).
Treatment 1 .891 .909
Treatment 2 .948 .963†
3.2.3. Intensity of Sensations. Across all 30 patients, the
Treatment 3 .913 .856
sensations that were rated with the highest intensity in
Treatment 4 .868 .880† response to treatment included soreness, dull pain, and sharp
Treatment 5 .893 .907† pain. Those rated at the lowest intensity included cold and
Treatment 6 .875 .878 warmth. Descriptive statistics for each sensation are listed in
All measures of the internal consistency of the MASS administered to 30 Table 4.
subjects are reported as Cronbach’s alpha; 𝑁 = 29 due to missing data set After Bonferroni corrections for multiple comparisons
indicated by †. (𝑃 < .0038), intensity ratings of soreness (𝐹(2, 27) = 7.74,
𝑃 = .002) and aching (𝐹(2, 27) = 7.55, 𝑃 = .002)
differed significantly across treatment groups (high versus
ranged from .928 to .768). In short, 11 of the 12 sensations low versus sham). Post hoc comparisons of soreness and
on the MASS were rated reliably with the exception of cold aching demonstrated that there was no significant difference
(ICC = .078, 𝑃 = .37), and heaviness was rated most reliably between the high- and low-dose real acupuncture groups and
across all sessions (ICC = .928, 𝑃 < .001). that those subjects in the sham group reported significantly
Further analysis of each treatment group indicated that, less soreness and aching as compared to the high-dose (𝑃 =
in the high-dose acupuncture group, heaviness (ICC = .88, .01 and 𝑃 = .05, resp.) and low-dose (𝑃 = .003 and 𝑃 =
𝑃 < .001) was rated the most reliably. In the low-dose .002, resp.) acupuncture treatment groups. Reported intensity
acupuncture group, deep pressure (ICC = .943, 𝑃 < .001) ratings for each individual sensation are depicted in Table 4.
and fullness/distention (ICC = .943, 𝑃 < .001) were To further elucidate the differences between real and
rated the most reliably. In the sham acupuncture treatment sham acupuncture, data from the low- and high-dose
group, numbness was rated most reliably (ICC = .932, acupuncture groups were pooled to increase power. After
𝑃 < .001). None of the treatment groups reliably rated the correction for multiple comparisons (𝑃 < .0038), sensations
Evidence-Based Complementary and Alternative Medicine 7

Table 3: Test-retest reliability of deqi sensations.

All High Dose Low Dose Sham


Soreness .889 (<.001) .721 (.002) .925 (<.001) .688 (.004)
Aching .913 (<.001) .726 (.002) .922 (<.001) .777 (<.001)
Deep pressure .903 (<.001) .808 (<.001) .943 (<.001) .821 (<.001)
Heaviness .928 (<.001) .88 (<.001) .926 (<.001) .769 (<.001)
Fullness/distention .921 (<.001) .831 (<.001) .943 (<.001) .872 (<.001)
Tingling .839 (<.001) .848 (<.001) .795 (<.001) .81 (<.001)
Numbness .861 (<.001) .839 (<.001) .837 (<.001) .932 (<.001)
Sharp pain .768 (<.001) .486 (.069) .812 (<.001) .761 (.001)
Dull pain .845 (<.001) .583 (.026) .874 (<.001) .871 (<.001)
Warmth .74 (<.001) .664 (.007) .661 (.008) .894 (<.001)
Cold .078 (.37) .467 (.08) −.052 (.493) −.15 (.559)
Throbbing .792 (<.001) .774 (<.001) .601 (.02) .876 (<.001)
Other .681 (<.001) −.75 (.508) .641 (.011) .741 (.001)
Sum .907 (<.001) .792 (<.001) .922 (<.001) .901 (<.001)
Mass index .907 (<.001) .764 (.001) .927 (<.001) .902 (<.001)
All test-retest reliability analyses reported as intraclass correlation coefficients (𝑃 value).

Table 4: Comparison of intensity ratings and MASS Index across acupuncture treatment groups.

All High Dose Low Dose Sham


Soreness∗ 1.29 ± 1.21 1.69 ± .86 1.89 ± 1.47 .28 ± .34
Aching∗ 1.09 ± 1.14 1.25 ± .8 1.83 ± 1.4 .2 ± .3
Deep pressure 1.05 ± 1.13 1.1 ± .98 1.51 ± 1.53 .55 ± .57
Heaviness .80 ± 1.12 .67 ± .94 1.54 ± 1.42 .2 ± .25
Fullness/distention .71 ± 1.04 .68 ± .86 1.25 ± 1.42 .18 ± .38
Tingling 1.21 ± 1 1.61 ± 1.21 1.26 ± 1 .77 ± .64
Numbness .70 ± .87 .82 ± .89 .96 ± 1.01 .33 ± .61
Sharp pain 1.43 ± 1.05 1.9 ± .84 1.63 ± 1.25 .76 ± .71
Dull pain 1.35 ± 1.1 1.55 ± .78 1.85 ± 1.38 .65 ± .73
Warmth .48 ± .59 .4 ± .63 .66 ± .54 .38 ± .62
Cold .06 ± .15 .06 ± .13 .11 ± .22 .02 ± .04
Throbbing∗ .63 ± .81 1.13 ± 1.1 .63 ± .53 .15 ± .32
Other .19 ± .34 .08 ± .19 .12 ± .19 .37 ± .49
Sum score∗ 10.99 ± 9.3 12.95 ± 7.55 15.22 ± 11.9 4.82 ± 3.79
MASS index∗ 1.62 ± 1.13 1.96 ± .84 2.10 ± 1.38 .80 ± .62
Values presented as mean ± standard deviation. Significant differences between acupuncture mode (real versus sham acupuncture) after correction for multiple
comparisons indicated by ∗.

of soreness (𝑃 < .001), aching (𝑃 < .001), and throbbing treatments. No significant difference was observed between
(𝑃 = .003) were rated significantly more intensely in the high- and low-dose acupuncture groups for the MASS Index
real acupuncture group compared to the sham acupuncture (𝑃 = .949) or the total MASS score (𝑃 = .617).
group.
The average total MASS score (sum of the intensities of
each sensation) differed significantly across the acupuncture 3.2.4. Frequency of Sensations. A chi-square test for inde-
treatment groups (high versus low versus sham) (𝐹(2, 27) = pendence indicated that there was a significant effect of
4.21, 𝑃 = .026). Similarly, the MASS index, or overall acupuncture dose (high versus low versus sham) on the
perceived sensation of acupuncture, differed significantly number of individuals reporting soreness (𝜒2 (2, 𝑁 = 30)
across the acupuncture treatment groups (𝐹(2, 27) = 5.03, = 6.24, 𝑃 = .044) and that there was a trend for aching (𝜒2
𝑃 = .014). Those who received sham acupuncture had a (2, 𝑁 = 30) = 5.96, 𝑃 = .051) and fullness/distension (𝜒2 (2,
significantly lower MASS index and total MASS score than 𝑁 = 30) = 5.83, 𝑃 = .054). Further comparisons between
those who received either high-dose (𝑃 = .04 and trend 𝑃 = acupuncture modes (real versus sham) indicated that there
.1, resp.) or low-dose (𝑃 = .02 and 𝑃 = .03, resp.) acupuncture was a significant effect of acupuncture mode on frequency of
8 Evidence-Based Complementary and Alternative Medicine

Table 5: By sensation, the number of individuals in each group who Table 6: Results of principal component analysis.
reported the sensation at least once across a total of 6 treatment
sessions (assessed twice per treatment). Variable Factor 1 Factor 2
Heaviness .90 —
All High dose Low dose Sham
Fullness/distension .87 —
Soreness∗ 25 10 9 6 Dull pain .81 —
Aching∗ 21 9 9 5 Cold .81 —
Deep pressure 27 9 10 8 Deep pressure .75 .55
Heaviness 20 7 7 6 Soreness .75 .40
Fullness/distention∗ 18 8 7 3 Aching .75 .55
Tingling 26 10 8 8 Numbness .60 .56
Numbness 20 7 7 6 Sharp pain .54 .71
Sharp pain 28 10 10 8 Warmth .42 .49
Dull pain 28 10 10 8 Throbbing — .95
Warmth 17 5 8 4 Tingling — .85
Cold 8 3 3 2
Throbbing 18 7 7 4
Other 11 2 4 5 Due to the similarity between high- and low-dose
Sensations with significantly different frequencies across groups (real versus acupuncture with regard to intensity of sensations, we
sham acupuncture) are denoted with a ∗. grouped the subjects receiving real acupuncture (both high
and low dose) and added acupuncture mode (real or sham
acupuncture) as a variable in our model to determine whether
reporting soreness, aching, and fullness/distension (𝑃 < .05). any of the sensations elicited were related to a single mode
The total number of individuals reporting each sensation is of acupuncture. The results of the PCA using acupuncture
listed in Table 5. mode as an additional variable identified three components
A one-way ANOVA comparing the total number of with eigenvalues greater than 1.0, accounting for a total of
sensations reported by each subject across treatment groups 82% of variance (see Table 7). The KMO measure of sampling
(high versus low versus sham) revealed a trend in the effect of adequacy was .824, and Bartlett’s test of sphericity was
acupuncture dose (𝐹(2, 27) = 2.68, 𝑃 = .087). Further com- significant (𝜒2 (78) = 396.50, 𝑃 < .001), again indicating that,
parison of the real and sham acupuncture treatment groups after including acupuncture mode, the data were still suitable
using an independent sample t-test (equal variances not for factor analysis. Again, variables related to localized deep
assumed according to Levene’s test for equality of variance) pressure sensations loaded onto the first factor, and variables
showed that those who received real acupuncture reported related to spreading sensations loaded onto the second
significantly more sensations during treatment (𝑡(25.37) = factor. Two complex variables (aching and soreness) loaded
−2.65, 𝑃 = .014) compared to the sham acupuncture group. onto the third factor with acupuncture mode, providing
Subjects who received real acupuncture reported an average further evidence that aching and soreness are associated with
of 5.79 ± 3.27 (mean ± SD) sensations during each treatment, acupuncture mode (real versus sham).
while those who received sham reported experiencing 3.12 ±
2.19 sensations. 3.2.6. Relation to Clinical Outcomes. To explore the relation-
ship between acupuncture sensations and clinical outcomes,
3.2.5. Principal Component Analysis. To further investigate we performed Pearson’s correlation analyses on the MASS
the clustering of deqi sensations, principal components anal- index and KOOS subscales across all three groups. Results
ysis (PCA) with Varimax rotation of components and Kaiser showed that there were no significant correlations between
normalization was applied to the acupuncture sensations the overall perceived intensity of sensations (MASS index)
for all subjects. Two components with eigenvalues greater and changes (baseline versus endpoint) in any of the subscales
than 1.0 were identified, accounting in total for 77.4% of of the KOOS. For exploratory purposes, we also performed
the variance. In this analysis, we used a factor loading a PCA to model whether specific sensations were related to
cutoff of 0.4. The Kaiser-Meyer-Olkin (KMO) measure of each subscale of the KOOS. For the pain and QOL subscales,
sampling adequacy was .824, and Bartlett’s test of sphericity two components were identified with eigenvalues greater
was significant (𝜒2 (66) = 385.65, 𝑃 < .001) indicating than 1.0 with a factor loading cutoff of 0.4, and for symptom,
that the data were suitable for factor analysis. While some ADL and sport, three components were identified. For each
variables loaded on a single factor, other variables loaded on of the KOOS subscales, the KMO measure of sampling
both factors, providing evidence of the complex nature of adequacy ranged from 0.802 to 0.819, and all Bartlett’s tests
some of the sensations (see Table 6). The variables loading of sphericity were significant (𝑃 < .001) indicating that the
onto a single factor can be characterized either by deep additional variables were suitable for factor analysis. Changes
pressure sensations (heaviness, fullness/distension, dull pain, in both pain and QOL loaded onto a factor with tingling,
and cold) or sensations related to “spreading sensations” throbbing, and sharp pain. For changes in function in daily
(tingling, throbbing). living and in sport, the acupuncture sensations loaded onto
Evidence-Based Complementary and Alternative Medicine 9

Table 7: Results of principal component analysis with acupuncture In this study, the average deqi sensation was of relatively
mode (real versus sham) included as an additional variable. weak intensity compared to previously reported acupuncture
sensations [26, 39]. For the present study, the average inten-
Variables Factor 1 Factor 2 Factor 3
sity for each sensation was between .06 and 1.89, compared
Heaviness .90 — —
to our previous studies, where average intensity of each
Fullness/distension .88 — — sensation was between 0 and 4 [26] and between 0.1 and 3.7
Deep pressure .78 .54 — [39]. We believe that this may be due to the age of patients in
Cold .78 — — the present study (58 ± 8.3) compared to studies conducted
Dull pain .77 — — in healthy, young subjects (29 ± 7 [26] and 26.4 ± 4.9 [39]).
Aching .70 .485 .42 We speculate that one difference between these populations is
Soreness .66 — .56 that the peripheral nervous system in these older patients may
Numbness .64 .58 — not be as sensitive as other younger populations. Additionally,
Warmth .52 .60 — we note that there are differences in the specific acupoints
needled and the disorder treated in this study compared to
Sharp pain .50 .64 —
previous studies, which may also influence the intensity of the
Throbbing — .91 —
sensations reported.
Tingling — .80 — In this study, knee OA patients across all treatment groups
Acupuncture mode (real versus sham) — — .81 tended to report soreness, deep pressure, tingling, dull pain,
and sharp pain, among others, all of which are typical deqi
sensations based on traditional Chinese medicine. Compared
two different factors, and the KOOS subscale score loaded with real acupuncture, sham acupuncture using a placebo
onto a third factor with a negative correlation with warmth. needle evoked very mild sensations, implying that superfi-
For changes in symptoms, the KOOS subscale score did not cial stimulation may be associated with different subjective
load onto a component with any of the sensations, indicating sensations than deep tissue stimulation. This is consistent
that it did not covary with any of the sensations (see Table 8 with previous studies that reported greater deqi sensations in
for the results of the PCA with each KOOS subscale included real compared to placebo acupuncture [20]. In the present
as an additional variable). study, soreness and aching were reported as significantly
Post hoc tests were conducted to verify the associations more intense in the real acupuncture group compared to the
indicated by the PCA between the MASS sensations and each sham acupuncture group.
subscale of the KOOS that loaded together. This exploratory Our results showed that sensations were equally reliable
analysis revealed a significant correlation between the inten- in the low-dose real acupuncture group as they were in
sity of the throbbing sensation and endpoint QOL subscale the sham acupuncture group, but less reliably in the high-
of the KOOS controlling for baseline QOL score (𝑟 = .477, dose real acupuncture group. This may be due to the fact
𝑃 = .009) as well as the intensity of the tingling sensation and that subjects were asked to report their average sensations
the QOL subscale score at endpoint controlling for baseline across all of the needles, and the number of needles differed
QOL (𝑟 = .368, 𝑃 = .049). No other comparisons were between groups. For the low-dose acupuncture group, sub-
significant when Pearson’s correlations were tested. jects reported the average intensity of each sensation across
two needles; however, for the high-dose acupuncture group,
subjects reported the average intensity of each sensation
3.3. Blinding. At the end of the study, all subjects were across all 6 needles, which is a complex task that could add
asked to complete a set of final questions to assess how additional variability to the data. For the sham acupuncture
well subject blinding was maintained throughout the study. group, subjects reported fewer sensations in total, meaning
Ninety percent (𝑁 = 27) of the subjects believed that the that there was less room for variability in the repeated report
needle was inserted into the skin in every session. The 3 of sensations.
subjects who believed that the needle was not inserted were Overall, the most reliably rated sensation was heaviness,
in the real acupuncture (low dose) group. and the least reliably rated sensation was coldness. We suspect
that the reliability of the sensations may be related to the
4. Discussion disorder studied (in this case, knee OA). Some experts believe
that the exact deqi sensations elicited are specific to the
In this longitudinal clinical trial, we investigated the descrip- physical conditions or the properties of the disorder [6]. It is
tive nature of deqi in knee OA patients. We found that in not surprising that cold sensations were rated the least reliably
real acupuncture treatment, soreness, deep pressure, dull because they were also rated the least frequently. Sensations
pain, and sharp pain were the most frequently reported such as coldness are generally included in acupuncture
sensations. The intraclass correlation analysis indicated that sensations scales because coldness and warmth are two of
most of the sensations on the MASS (with exception of cold) the earliest sensations described in the ancient literature and
were reported reliably across different treatment sessions, are symptom specific [2]. For some disorders that present
implying that the deqi sensation can be reliably measured with symptoms such as fever, acupuncture can produce cold
within subjects using scales such as MASS in a chronic pain sensations to counterbalance these symptoms. The knee OA
population. patients in our study did not tend to report these symptoms
10 Evidence-Based Complementary and Alternative Medicine

Table 8: Results of principal component analysis with the KOOS subscales included as additional variables.

Pain Symptom ADL Sport QOL


1 2 1 2 3 1 2 3 1 2 3 1 2
KOOS — .65 — — .96 — — −.84 — — −.74 — .76
Soreness .81 — .76 — — .78 — — .80 — — .83 —
Aching .87 — .76 .53 — .76 .54 — .76 .54 — .86 —
Deep pressure .88 — .77 .53 — .72 .57 — .70 .55 — .87 —
Heaviness .95 — .91 — — .84 — — .83 — — .93 —
Fullness distension .93 — .88 — — .81 — — .79 — — .91 —
Tingling .47 .72 — .85 — — .82 — — .81 — .46 .73
Numbness .76 — .62 .55 — .54 .57 — .53 .56 — .78 —
Sharp pain .74 .50 .56 .70 — .59 .68 — .62 .67 — .73 .51
Dull pain .87 — .82 — — .82 — — .82 — — .86 —
Warmth .59 — .45 .47 — — .55 .52 — .54 .69 .56 —
Cold .73 — .81 — — .87 — — .88 — — .75 —
Throbbing — .84 — .95 — — .94 — — .92 — — .86

during the acupuncture treatment. We speculate that this may consistent with previous studies that indicate that stronger
be the reason for few patients reporting cold sensations. deqi sensation can produce better clinical outcomes [21, 22,
The characterization of deqi sensations is useful for high- 24]. In exploratory analyses, we found that tingling and
lighting the differences between real and sham acupuncture throbbing were related to clinical outcomes. It is important
experiences. Using a principal component analysis (PCA), to note, however, that these analyses are highly exploratory
we were able to segment the acupuncture sensations into in nature due to small sample size and are not corrected for
meaningful categories. The results of this study indicate multiple comparisons. Specific investigation of the relation-
that deqi sensations on the MASS fall into one and/or two ship between clinical outcomes and deqi sensations is needed
categories. One category of sensations we observed includes to further confirm these findings.
those sensations related to localized deep pressure. Sensations In an earlier study by Takeda and colleagues, researchers
such as heaviness, fullness/distension, dull pain and cold investigated the effect of real and sham acupunctures on
are common traditional Chinese acupuncture sensations and osteoarthritis (OA) and found that the experience of deqi
have previously been reported in relation to deep tissue can be used as a predictor for significant improvement
stimulation [40]. The other category of sensations identified [17]. In four subsequent OA studies comparing the effect
by the PCA includes those sensations related to “spreading of real acupuncture treatment to sham (minimal depth
sensations” (such as tingling and throbbing). Both of these needling) acupuncture, three studies [21, 22, 41] found that
components are important factors in traditional Chinese real acupuncture produced significantly better therapeutic
acupuncture. The remaining sensations loaded onto both effects than sham acupuncture. The fourth study [23] showed
factors and can be viewed as a combination of the two no significant difference between real and sham acupuncture
factors. These results are in line with previous studies which treatments and further concluded that “deqi sensation[s] do
have found that certain acupuncture sensations with similar not result in marked effect,” which calls into questioning
characteristics tend to cluster together [9, 10]. “whether deep needling with stimulation and deqi sensation
Using the PCA, we were also able to conduct an additional is superior to shallow needling.”
analysis to identify which of the acupuncture sensations One potential limitation of this study is the small sample
might be related to acupuncture mode (real versus sham size. We believe, however, that this data will provide the basis
acupuncture) and to clinical outcomes (KOOS). The present for a power analysis of larger clinical trials in the future.
study suggests that patients in the real acupuncture groups
report sensations such as soreness and aching significantly 5. Conclusion
more intensely compared to patients in the sham acupunc-
ture group. Exploratory component analyses indicated that In the present longitudinal treatment study, we found that
tingling and throbbing may be associated with improvements patients with knee OA reliably reported sensations such as
in clinical outcomes. heaviness, fullness/distension, aching, and deep pressure that
Researchers continue to debate whether certain sensa- are in coherence with the traditional Chinese acupuncture
tions or the perceived intensity of those sensations are related theory. Compared with sham acupuncture, real acupuncture
to clinical outcomes [17, 20–24]. In this study, we found that tends to produce stronger deqi sensation and better clini-
real acupuncture, which produced stronger deqi sensations, cal outcomes. Soreness and aching were implicated as the
could also produce significant improvement in pain and two key sensations that differentiate real acupuncture with
function compared with sham acupuncture. This result is needle insertion from superficially stimulated acupuncture.
Evidence-Based Complementary and Alternative Medicine 11

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